FDA Guidance On Transitioning COVID-19 EUA Products Has US Firms Watching The Clock
Stakeholders across medtech industry submit comments on FDA's itsplans to help companies looking to keep their EUA products on the market post-pandemic.
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FDA Outlines Phased Approach To Return Products To Full Compliance After Emergency Use Ends
The US FDA says in a new draft guidance document that makers of a variety of devices and diagnostics that were given wide enforcement berth by the agency to use their products to respond to COVID-19 must eventually transition back to full regulatory compliance under a proposed three-phase plan.
News We’re Watching: Medtronic To Buy EOFLow, Neuralink Cleared For Human Trials, NICE Backs Genetic Tests
This week, Medtronic said it would pay $738m for insulin patch firm EOFlow; Neuralink got an FDA OK for first-in-human trials; and UK agency NICE backed genetic tests for stroke patients and digital therapeutics for mental health conditions.
White House Takes Steps To Advance ‘Responsible’ AI That ‘Upholds Democratic Values’
The White House Office of Science and Technology Policy has released an updated national strategic framework outlining priorities and goals for federal investment in AI. Industry executive Peter Shen weighs in on the plan.